[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microbiome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microbiome":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,42,77,101,134,166,192,215,245,266,290,321,345,376,399,417,447,471,493,524,545,571,602,630,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637188","evaluation-of-gixams-efficacy-predicting-the-presence-of-advanced-and-non-advanced-colorectal-neoplasia-in-a-fit-negative-population-100637188",false,"NCT07623902","Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population","Inclusion Criteria:\n\n1. Participants aged ≥45 - ≤84 years.\n2. Able to provide a signed informed consent.\n3. Considered by a physician or healthcare provider as being of 'average risk' for CRC.\n4. Scheduled for a screening colonoscopy at investigation site.\n\nExclusion Criteria:\n\n1. Undergoing colonoscopy for investigation of symptoms.\n2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.\n3. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.\n4. Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.\n5. History of colorectal cancer.\n6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.\n7. Participant has a diagnosis or medical \u002F family history of any of the following conditions, including:\n\n   * Familial adenomatous polyposis (also referred to as \"FAP\", including attenuated FAP and Gardner's syndrome)\n   * Hereditary non-polyposis CRC syndrome (also referred to as \"HNPCC\" or \"Lynch Syndrome\")\n   * Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.\n8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and\u002For Crohn's disease.\n9. Participants with a disability to extend their tongue.\n10. Participants with tongue tremor.\n11. Participants with tongue piercing.\n12. Participants that had a dental visit in the 7 days prior to the Gixam test.\n13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.\n14. Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.\n15. Participant is pregnant.\n16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.","ALL","45 Years","84 Years",{"count":20,"type":21},1436,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are:\n\n1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result?\n2. Is the use of the Gixam device safe?\n\nGixam test result will be compared to the findings of a standard of care screening colonoscopy.\n\nStudy participants will:\n\n1. Undergo the Gixam test\n2. Take a FIT at home and ship to a laboratory.\n3. Undergo a standard of care screening colonoscopy.",[27,28],"CRC Screening","Microbiome","RECRUITING","2026-05-28",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":33},"2026-05-18",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"Jubaan Ltd.","INDUSTRY",5,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100607970","smoothie-program-for-achieving-and-resilient-kids-100607970","NCT07195474","Smoothie Program for Achieving and Resilient Kids","Effect of Daily Yogurt Smoothies on Neurocognitive Function in Children","SPARK","Inclusion Criteria:\n\n* Children should be of good health, without presence of any metabolic, gastrointestinal, or developmental disorders (e.g., ADHD, autism, etc.).\n* Children should not be taking medications that impact appetite or cognitive function.\n* Children must be willing to consume and report liking the fermented dairy smoothie.\n* Children should be between the ages of 7-9 years-old at enrollment.\n* Children should speak English fluently.\n\nExclusion Criteria:\n\n* They are not within the age requirements (\\\u003C 7 years-old or \\> 9 years-old) at baseline.\n* They have known emotional or cognitive delays, so that we can be assured that they understand the procedures.\n* They do not speak English fluently.\n* They have parentally reported medical problems that affect the digestive system or ability to eat yogurt (e.g., lactose intolerance, food allergies, Crohn's disease, Celiac disease, Esophagitis) and\u002For are taking a prescription medication that may affect appetite (e.g., Ritalin, methylphenidate, Adderall XR, Concerta, Vyvanse, etc.).\n* They are not from families of rural communities (assessed by National Center for Education Statistics local classifications).\n* Their parent is unable to attend the study visits.",true,"7 Years","9 Years",{"count":54,"type":21},60,[24],"The proposed study will examine whether eating yogurt every day can improve brain and gut health in children. Prior research suggests that yogurt may support cognitive functions like self-control, but more studies are needed to confirm this. The study will follow 60 children from Central Pennsylvania, ages 8 to 10, who will be randomly assigned to drink either fruit juice (control group) or yogurt smoothies once or twice a day for four weeks.\n\nResearchers will compare how different amounts of yogurt affect children's thinking skills (like memory and focus), brain activity, and gut bacteria. These changes will be measured through brain scans, computer-based thinking tasks, surveys, and stool samples. The study will also collect information about children's overall diet. The goal is to find out if yogurt can support healthy brain and gut development and to determine the right amount to include in a child's daily diet. Results will help guide future research on how nutrition supports children's health.",[58,28,59],"Executive Functions (EF)","Dietary Quality",[61,62,63,64,65],"Cognitive Function","daily yogurt smoothies intake","gut and brain health","hippocampal-dependent memory","dose-dependent","NOT_YET_RECRUITING",{"date":68,"type":33},"2026-05-20",{"date":70,"type":21},"2026-05",{"date":72,"type":21},"2028-09",{"name":74,"class":75},"Penn State University","OTHER",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":76},"100637418","early-phase-1-development-of-a-preparation-for-supportive-supplementation-of-probiotics-in-patients-with-reflux-100637418","NCT07600008","Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux","Inclusion Criteria:\n\n* Diagnosed GERD.\n* Stable health without current complications.\n* Patients on stable pharmacological PPI therapy (rabeprazole).\n\nExclusion Criteria:\n\n* Use of probiotics or prebiotics within the last 4 weeks.\n* Pregnancy or breastfeeding.\n* Systemic antimicrobial therapy within the last 4 weeks.\n* Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks.\n* Serious chronic disease that could affect study results, including cancer, diabetes, inflammatory bowel disease, diagnosed SIBO.\n* Prior surgeries, especially fundoplication and resections of the esophagus or stomach.\n* Patients with psychiatric or cognitive disorders.\n* Hypersensitivity to components of the investigational product.","40 Years","55 Years",{"count":86,"type":21},50,[88],"EARLY_PHASE1","A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux.\n\nThe objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms.\n\nPatients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur.\n\nOral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.",[91,28,92],"Reflux Disease","Probiotics Supplement","2026-05-17",{"date":68,"type":33},{"date":96,"type":33},"2026-01-15",{"date":98,"type":21},"2026-07-30",{"name":100,"class":75},"University Hospital Olomouc",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":50,"sex":16,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":76},"100639426","effect-of-a-probiotic-or-postbiotic-on-gut-microbiome-during-antibiotic-treatment-100639426","NCT07594860","Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment","Assessment Of Gut Microbiome Changes During Antibiotic Treatment With Probiotic, Postbiotic Or Placebo: A Randomized, Triple-blind, Placebo-controlled Pilot Study.","POTATO-2","Inclusion Criteria:\n\nParticipants meeting ALL of the following criteria will be recruited for the study:\n\n* Males and females aged ≥18 to ≤ 65 years; if female, either not of childbearing potential or using a medically approved method of birth control and willing to take a pregnancy test at screening.\n* Body mass index (BMI) 18.5-29.9 kg\u002Fm².\n* Healthy as determined by medical history and physical examination.\n* Agreed not to change current dietary habits during the course of the study.\n* Able to attend study visits, comply with study requirements (consumption of study medications, especially biological sample collection procedures, and study visit schedule) and provide reliable and complete data regarding AEs\u002FSAEs and PROs.\n* Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.\n\nExclusion Criteria:\n\nParticipants meeting ANY of the following criteria will be excluded from the study:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the study.\n* People on vegetarian or vegan diet; People on special diet (e.g. Ducan, Keto, etc.)\n* BMI ≥ 30 kg\u002Fm² or \\\u003C18.5 kg\u002Fm².\n* History of intake of antibiotics, other probiotics, postbiotics, prebiotics, synbiotics, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), within six months prior to the screening day.\n* Participation in other clinical trials in the last 90 days prior to screening.\n* Allergy to any penicillin antibiotic or any other beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).\n* History of jaundice\u002Fhepatic impairment due to amoxicillin\u002Fclavulanic acid.\n* Active smokers or using any form of smokeless tobacco.\n* Participants with substance abuse problems (within two years) defined as:\n\n  * Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)\u002F Nicotine dependence.\n  * High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol-containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men.\n* Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and\u002For any inflammatory disorder, tumour, and other gastrointestinal diseases.\n* Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.\n* Participants actively using GLP1 agonist drugs (Wegovy, Semiglutide etc.) or completed treatment with said medication less than 12 weeks before screening.\n* Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.","18 Years","65 Years",{"count":112,"type":21},126,[24],"This study assesses the effects of a probiotic or postbiotic on gut microbiome during antibiotic treatment.",[28],[117,118,119,120,121,122,123,124],"Antibiotic","Dysbiosis","Microbiome composition","Antibiotic Resistance Genes","Microbiome Recovery","Antibiotic Scarring","Probiotic","Postbiotic","2026-05-12",{"date":127,"type":33},"2026-05-19",{"date":129,"type":21},"2026-06-01",{"date":131,"type":21},"2027-05-31",{"name":133,"class":40},"The Archer-Daniels-Midland Company",{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":16,"minAge":83,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100572506","care-crc-microbiome-insights-and-correlations-for-risk-and-outcomes-in-colorectal-cancer-100572506","NCT06734156","CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer","CARE-CRC","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent\n* Resident in Portugal\n* Age from 40 to 74 years\n* Have a recent diagnosis of CRC without initiating any treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years or ≥ 75 years\n* Unable to provide informed consent\n* Refusal to provide stool samples\n* Previous or current treatment for CRC\n* First-degree family history of CRC\n* Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile\n* Pregnancy","74 Years",{"count":143,"type":21},400,"OBSERVATIONAL","Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths globally, with increasing incidence rates. While predominantly affecting older adults, CRC cases among individuals under 50 (early-onset CRC, or EoCRC) are rising. This age group rarely undergoes routine screening, resulting in delayed diagnoses and more advanced disease at presentation. In the USA, EoCRC accounts for 10% of CRC cases and is the leading cause of cancer-related deaths in men under 50.\n\nDespite the increase in EoCRC incidence, the causes remain unclear. Only 25% of cases have a CRC family history, suggesting environmental factors. Diets low in fibre and rich in fat and red meat, obesity, alcohol consumption, sedentary lifestyle, stress, and chronic inflammation of the GI tract are estimated to account for 70-90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented through lifestyle changes, particularly in diet and physical activity.\n\nThese lifestyle factors are also strongly linked to changes in the gut microbiome, which differs markedly between CRC patients and healthy individuals. The microbiome may influence tumour development by producing metabolites that regulate immune responses or create anti-tumour environments. Thus, the gut microbiome is a promising target for early CRC detection and prevention.\n\nThis study aims to develop a non-invasive, microbiome-based diagnostic tool for CRC, identifying biomarkers to improve early detection, personalise treatment, and reduce healthcare costs.",[147,28,148],"Colorectal Cancer (CRC)","Early Onset Colorectal Cancer",[150,151,28,152,153,154,155,156],"Colorectal Cancer","Gut Microbiota","Early-onset Colorectal Cancer","Biomarkers","Diet","Risk factors","Metagenomics","2026-05-11",{"date":125,"type":33},{"date":160,"type":33},"2026-03-02",{"date":162,"type":21},"2029-12-02",{"name":164,"class":75},"Gulbenkian Institute for Molecular Medicine",2,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":50,"sex":16,"minAge":83,"maxAge":141,"enrollmentInfo":174,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":76},"100573055","improving-colorectal-cancer-early-screening-in-portugal-identification-of-gut-microbiome-biomarkers-in-stool-gutbiome-pt-100573055","NCT06741293","Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)","Improving Colorectal Cancer Early Screening in Portugal: Identification and Validation of Biomarkers of Gut Microbiome in Stool","GUTBIOME-PT","Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study procedures\n* Reside in the Lisbon Metropolitan Area,, Portugal\n* Age from 40 to 74 years\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years or ≥ 75 years\n* Unable to provide informed consent\n* Refusal to provide stool samples\n* Active oncological disease\n* Personal history of CRC\n* Personal history of colon adenomas removed in the last 24 months\n* First-degree family history of CRC\n* Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, persistent and infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology or recurrent infection by Clostridioides difficile\n* Severe cardiovascular or heart diseases with medical diagnosis\n* Severe renal failure requiring hemodialysis\n* Severe lung disease\n* Pregnancy",{"count":175,"type":21},30000,"Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \\\u003C50 years of age.\n\nEarly detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions.\n\nRecent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and\u002For high-risk adenomas to improve early detection.",[178,147,28],"Colorectal Cancer Screening",[180,181,182,183,184],"colorectal cancer","microbiome","colorectal cancer screening","biomarkers","metagenomics",{"date":186,"type":33},"2026-05-14",{"date":188,"type":33},"2023-11-28",{"date":190,"type":21},"2029-11-28",{"name":164,"class":75},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":200,"minAge":109,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":76},"100616859","feasibility-of-a-lifestyle-intervention-for-women-with-triple-negative-breast-cancer-under-neoadjuvant-immunotherapy-100616859","NCT07311083","Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy","Feasibility of a Lifestyle Intervention to Switch to a High-fiber, Gut-healthy Diet in Women With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy: a Randomized Controlled Trial","BallastImmun","Inclusion Criteria:\n\n* Female patients aged 18-75\n* Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy\n* Willingness to participate in the study and signed consent form\n\nExclusion Criteria:\n\n* Advanced stage of disease with metastases\n* Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study\n* Pregnancy\n* Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions\n* A diet that is incompatible with a high-fiber diet, such as the ketogenic diet\n* Abuse of drugs and\u002For alcohol\n* Inability to complete the questionnaires independently\n* Colectomy\n* Gastrointestinal stenosis\n* Fructose intolerance\n* Histamine intolerance\n* Gluten intolerance\n* Ketogenic diet\n* Unwillingness to refrain from taking probiotics for the duration of the study\n* Eating disorders\n* No laptop and\u002For camera available to participate in the online group training program","FEMALE","75 Years",{"count":54,"type":21},[24],"Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients.\n\nStudies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved.\n\nThe aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.",[28],"2026-05-05",{"date":208,"type":33},"2026-05-08",{"date":210,"type":33},"2026-02-01",{"date":212,"type":21},"2027-07-01",{"name":214,"class":75},"Kliniken Essen-Mitte",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":50,"sex":16,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":76},"100478816","phase-2-effects-of-cannabidiol-and-tetrahydrocannabinol-on-microbiome-and-neuroinflammation-in-hiv-100478816","NCT05514899","Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV","Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV","CAMI","1. Aged 21 to 70 years old\n2. Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.\n3. Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)\n4. No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.\n5. Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention\n6. Individuals with HIV must meet the following criteria\n\n   1. Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)\n   2. Stage 1 or 2 infection\n   3. Have a \"normal\" CD4 count defined as ≥350 cells\u002Fmicroliter\n   4. No significant history of ART regimen adherence challenges\n7. Ability to adhere to the study visit schedule.\n\nExclusion Criteria:\n\n1. Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;\n2. Significant cognitive impairment such as Dementia, including Alzheimer's disease\n3. Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential\n4. Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;\n5. Evidence of significant cardiovascular risk, resting heart rate \\\u003C50 or \\>110 beats per minute, uncontrolled hypertension (systolic blood pressure \\\u003C80 or \\>140 mmHg; diastolic blood pressure \\\u003C50 or \\>90 mmHg), history of myocardial infarction, congestive heart failure, or arrhythmia);\n6. Evidence of chronic pulmonary disease requiring supplemental oxygen;\n7. Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the upper limit of normal at screening;\n8. Insulin dependent diabetics\n9. Allergy to the study drugs or any of their constituents including sesame\n10. Use of medications with absolute contraindicated or potential significant interactions\n11. Use of sedating medications\n12. Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;\n13. Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as indexed by their Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression).\n14. Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's disease, and recent (past 3 months) cerebral infarction or hemorrhage with neurological sequelae.","21 Years","70 Years",{"count":226,"type":21},90,[228],"PHASE2","This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.",[231,232,233,234,235,28],"HIV","Cannabis","THC","Neuroinflammatory Disease","Neuroinflammatory Response","2026-04-27",{"date":238,"type":33},"2026-05-01",{"date":240,"type":33},"2023-09-01",{"date":242,"type":21},"2027-10-31",{"name":244,"class":75},"University of California, San Diego",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":50,"sex":16,"minAge":109,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":76},"100626752","the-effects-of-an-oral-nutritional-intervention-on-the-small-intestine-microbiome-100626752","NCT07439718","The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome","Inclusion Criteria:\n\n1. Males or females aged 18 to 60 years, inclusive, at enrollment.\n2. BMI of ≥18.5 but \\\u003C30 kg\u002Fm2.\n3. Healthy, as determined based on self-reported medical history.\n4. No planned change in diet or medical interventions during the study.\n5. Willing to collect fecal samples and retrieve sampling capsules from feces.\n6. Able to understand and to sign a written informed consent prior to study enrollment.\n7. Willing and able to comply with the requirements for participation in this study.\n\nExclusion Criteria:\n\n1. Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).\n2. Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.\n3. History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.\n4. History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.\n5. Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.\n6. Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.\n7. Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.\n8. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.\n9. Any concurrent cancer diagnosis, as reported by the participant.\n10. Any cancer treatment within the past year, as reported by the participant.\n11. History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.\n12. Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.\n13. Antibacterial\u002Fantifungal therapy in the past 3 months prior to enrolment, as reported by the participant.\n14. Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.\n15. Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.\n16. Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.\n17. Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).\n18. Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.\n19. Currently participating in another interventional study.\n20. Family or hierarchical relationships with the research team members.","60 Years",{"count":7,"type":21},[24],"This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.",[256,28],"Microbiome Composition","2026-04-21",{"date":259,"type":33},"2026-04-22",{"date":261,"type":33},"2026-02-23",{"date":263,"type":21},"2026-05-31",{"name":265,"class":40},"Société des Produits Nestlé (SPN)",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":275,"conditions":276,"keywords":280,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":76},"100559651","monitoring-of-antimicrobial-resistance-based-on-metagenomics-analyses-in-pneumonia-patients-100559651","NCT06566898","Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients","Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients: a Genomic Epidemiology Study","Inclusion Criteria:\n\n* Patients clinically diagnosed as severe pneumonia and mild pneumonia are diagnosed according to the Guidelines for the diagnosis and Treatment of community-acquired pneumonia in Adults (2019 edition) formulated by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), who meet 1 of the following major criteria or ≥3 minor criteria can be diagnosed. The diagnostic criteria for severe and mild pneumonia in children were adopted by the British Thoracic Society (BTS) in 2011.\n* Clinical examination was performed, and there was biospecimen (nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid, sputum, blood, hydrothorax, lung tissue) remaining in the clinical microbiological examination.\n\nExclusion Criteria:\n\n* Patients whose biological samples may be contaminated;\n* Patients with alveolar lavage fluid or hydrothorax volume less than 200μl.",{"count":274,"type":21},800,"Monitoring of antimicrobial resistance (AMR) based on metagenomics analyses in pneumonia patients is critical for optimizing clinical diagnosis and treatment and improving clinical prognosis. This study is designed to ask the following key questions:\n\n1. What is the microbiome maps of patients with severe pneumonia and mild pneumonia ?\n2. How many pathogen resistance genes are carrying in severe pneumonia and mild pneumonia ?\n3. What is the genetic diversity of key pathogens detected in severe pneumonia and mild pneumonia during 2019-2025?",[277,278,28,279],"Pneumonia","Next-generation Sequencing","Antimicrobial Resistance",[277,281,28,279],"Next-generation sequencing",{"date":283,"type":33},"2026-04-23",{"date":285,"type":33},"2024-08-01",{"date":287,"type":21},"2026-09-30",{"name":289,"class":75},"Shanghai General Hospital, China",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":50,"sex":16,"minAge":109,"maxAge":83,"enrollmentInfo":298,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":300,"conditions":301,"keywords":307,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"100633895","microbiome-and-metabolome-profiles-in-couples-undergoing-ivf-and-reproductive-outcomes-100633895","NCT07532629","Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes","Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study","Mi IVF","Inclusion Criteria:\n\n* Women aged 18 to 40 years at enrolment.\n* Men aged between 18 to 56 years at enrolment.\n* Couples planning to undergo IVF treatment at a participating centre.\n* Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.\n\nExclusion Criteria:\n\n* Pregnancy at the time of enrolment (confirmed or suspected).\n* Recent systemic antibiotic use within the past 4 weeks\n* Active vaginal or genital tract infection at the time of sampling",{"count":299,"type":21},1000,"This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.",[302,303,304,305,306,28],"Infertility","Assisted Reproductive Technology","Pregnancy Complications","Pregnancy Loss, Early","Metabolome",[308,28,306,309,310],"IVF","Male fertility","Pregnancy outcome","2026-04-13",{"date":313,"type":33},"2026-04-16",{"date":315,"type":33},"2022-06-10",{"date":317,"type":21},"2029-03-01",{"name":319,"class":75},"Karolinska Institutet",3,{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":50,"sex":327,"minAge":328,"maxAge":83,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":76},"100633365","phase-4-assessing-changes-in-the-gut-microbiome-of-non-gastrointestinal-disordered-subjects-before-and-after-oral-prebiotic-supplementation-using-the-simba-capsule-100633365","NCT07525739","Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule","Inclusion Criteria:\n\n1. Aged 19-40 years old at the inclusion of the study, both female and male subjects.\n2. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.\n3. Willing to maintain their current lifestyle during the study.\n4. Able to swallow a 25mm length and 9mm width sized capsule.\n5. At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study.\n6. Signed Informed Consent, and willing to follow the study procedures, including consumption of study product per the protocol and completing any forms\u002Fquestionnaires needed throughout the study.\n\nExclusion Criteria:\n\n1. Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).\n2. Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.\n3. Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.\n4. Less than 3 bowel movements a week\n5. If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after\n6. Prior gastrointestinal surgery, or radiation treatment which, in the Investigator's opinion, may lead to intestinal stricturing or obstruction with a risk of capsule non-excretion, including, e.g., untreated achalasia, eosinophilic esophagitis, cancer diagnosis (depending on timing, location, and treatment) or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n7. History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction.\n8. Organic motility disorder (e.g., gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome) with a history of swallowing difficulty or oropharyngeal dysphagia.\n9. Use of metformin within 3 months prior to the start of the study\n10. Use of any oral or intravenous antibiotics within 3 months prior to the baseline study timepoint (topical antibiotics are acceptable).\n11. Use of probiotics, prebiotics, fibre (Metamucil, FibreOne, etc.) or any other supplements known to affect the gastrointestinal microbiota within 14 days prior to the baseline study timepoint.\n12. Known or suspected allergy or intolerance to the IP or its components.\n13. Pregnant or breastfeeding women.\n14. Excessive alcohol consumption or drug abuse.","MALE","19 Years",{"count":330,"type":21},30,[332],"PHASE4","This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.",[335,336,28,337],"Prebiotic","Metagenomic Next Generation Sequencing","Small Intestine","2026-04-06",{"date":311,"type":33},{"date":70,"type":21},{"date":342,"type":21},"2026-09",{"name":344,"class":40},"Nimble Science Ltd.",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":16,"minAge":109,"maxAge":201,"enrollmentInfo":352,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":353,"conditions":354,"keywords":361,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":76},"100613316","observational-study-of-gut-microbiota-in-abemaciclib-treated-patients-with-and-without-diarrhea-100613316","NCT07264998","Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea","Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years.\n2. Diagnosed with hormone receptor-positive (HR⁺) breast cancer.\n3. Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.\n4. Willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.\n3. Pregnant or lactating women.\n4. Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.",{"count":54,"type":21},"Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not.\n\nWhat will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase.\n\n* Patients who are already being treated with Abemaciclib will be invited to join.\n* They will be placed into one of two groups: those who experience diarrhea and those who do not.\n* Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.\n* Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.\n\nWho can participate?\n\n* Adult women (aged 18-75) diagnosed with HR-positive breast cancer.\n* Currently receiving treatment with Abemaciclib for at least 2 weeks.\n* Must be willing to provide informed consent and follow the study procedures.\n\nWhat are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.\n\nHow is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.",[355,356,357,358,359,360,28],"Breast Neoplasms","Hormone Receptor-Positive Breast Cancer","Abemaciclib","Abemaciclib-related Diarrhea","Drug-induced Diarrhea","Gastrointestinal Microbiome (Focus)",[357,362,363,28,364,365,366],"Hormone receptor-positive breast cancer","Drug-induced diarrhea","Gastrointestinal microbiome","Microbiome biomarkers","Abemaciclib-related diarrhea","2026-04-01",{"date":369,"type":33},"2026-04-03",{"date":371,"type":33},"2025-12-21",{"date":373,"type":21},"2026-07",{"name":375,"class":75},"Hubei Cancer Hospital",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":50,"sex":16,"minAge":109,"maxAge":251,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":76},"100631497","comparison-of-the-effects-of-oral-hygiene-regimens-on-clinical-immunomodulatory-and-microbial-outcomes-and-oral-tolerance-in-people-with-gingivitis-100631497","NCT07501455","Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis","Inclusion Criteria:\n\n2\\. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect).\n\n3\\. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit.\n\n4\\. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit.\n\n5\\. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit.\n\n6\\. Able to read and understand English. 7. Subject has signed the written informed consent (ICD) and indicated their agreement with the terms of the study and the study procedures listed and photograph release including the Health Insurance Portability and Accountability Act (HIPAA) disclosure prior to any study-related procedures.\n\n8\\. Generally, in good overall health based on the medical history reported by the subject.\n\n9\\. Has at least 18 natural teeth (not counting 3rd molars) with scorable facial and lingual surfaces.\n\n10\\. Willingness to use the assigned products according to instructions, availability for appointments, agreement to follow the subject responsibilities and likelihood of completing the clinical trial\n\nExclusion Criteria:\n\n1. Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.\n2. History of significant adverse reactions, including sensitivity or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye.\n3. Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.\n4. Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.\n5. Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.\n6. Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant (based on the examiner or PI's oral exam) cosmetic restorations.\n7. History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures.\n8. Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage.\n9. Suspected alcohol or substance abuse.\n10. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator, including a history of or a concurrent health\u002Fother condition\u002Fsituation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.\n11. Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.)\n12. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:\n\n    * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1 (81mg of aspirin is allowed).\\*\n    * Use of Immunosuppressive, or steroidal drugs therapy during the study or within 2 months before Visit 2. \\* Intermittent use (\\\u003C3 times per week) of certain anti-inflammatory medications is acceptable at the discretion of the investigator. Use of anticoagulant therapy within 1 month of screening visit or during the study.\n    * Use of systemic antibiotics within 1 month of screening visit and during the entire study.\n13. Is self-reported to be pregnant, in lactation, planning to become pregnant during the study, or positive pregnancy urine tests (females of child-bearing potential only):\n\n    * For females: Postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition prior to the first study IP administration) or premenopausal\u002Fperimenopausal state with an effective means of contraception.\n    * Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial. Medically acceptable forms of birth control that may be used by the subject and\u002For his\u002Fher partner include:\n\n      * Double barrier method (condoms, diaphragm or cervical cap with spermicide)\n      * Hormonal prescription contraceptives (i.e., oral, injectable, implanted, patch or vaginal ring hormone therapy)\n      * Intrauterine device (IUD)\n      * Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal ligation, hysterectomy and\u002For bilateral oophorectomy)\n      * Abstinence\n    * For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and for 30 days thereafter.\n14. Participation in any clinical trial within 30 days of the Screening visit.\n15. Subjects who were previously randomized into one of the study products as part of this study.\n16. Subjects who are related to the people who are involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Kenvue, contractors of Kenvue, and the families of each).\n17. Subjects within the same household as other subjects enrolled in the study at the same time.",{"count":383,"type":21},250,[24],"This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.",[28,387,388,389,390],"Cytokines","Plaque","Gingivitis","Gingival Bleeding","2026-03-26",{"date":393,"type":33},"2026-03-30",{"date":395,"type":33},"2026-02-26",{"date":206,"type":21},{"name":398,"class":40},"Kenvue Brands LLC",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":16,"minAge":109,"maxAge":83,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":413,"leadSponsor":415,"locationsCount":76},"100625674","probiotics-antibiotics-and-the-post-antibiotic-microbiota-100625674","NCT07425704","Probiotics, Antibiotics and the Post-Antibiotic Microbiota","Inclusion Criteria:\n\n1. Adults, aged 18-40.\n2. Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days.\n3. Willing to provide stool samples and, for women, vaginal samples.\n4. Willing to avoid consumption of any other probiotic capsules\u002Ftablets during the study.\n\nExclusion Criteria:\n\n1. If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue.\n2. Any antibiotic intake within the last 3 months.\n3. Immunodeficient or undergoing immunosuppressive therapy.\n4. Currently diagnosed with diabetes\u002Fcardiovascular disease\u002Fcancer\u002Fdementia.\n5. Any unexplained loss of weight in recent months.\n6. Known to be pregnant or \\\u003C3 months postpartum.",{"count":86,"type":21},[24],"Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy",[123,28],"2026-03-16",{"date":411,"type":33},"2026-03-18",{"date":311,"type":21},{"date":414,"type":21},"2026-12-01",{"name":416,"class":40},"Cultech Ltd",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":50,"sex":16,"minAge":424,"maxAge":110,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":434,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":443,"leadSponsor":445,"locationsCount":76},"100621380","evaluating-the-effects-of-nutritional-interventions-on-sleep-the-gut-microbiome-cognition-and-stress-100621380","NCT07369869","Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.","Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.","INCLUSION CRITERIA\n\n* Participants must self-assess themselves as being in good health.\n* Aged 25 to 60 years at the time of randomisation\n* Fluent in English\n* Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \\>5 on the Pittsburgh Sleep Quality Index (PSQI).\n\nEXCLUSION CRITERIA\n\n* Member of own household currently participating in this trial\n* Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and\u002For sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder\n* History of seizures or epilepsy\n* Shift working or have a history of shift work within the previous six months\n* Currently, or within the previous 8 weeks, consuming any nutritional supplements.\n* Participation in any other intervention research trials\n* Sleeping at a location other than their usual residence more than two nights per week during participation\n* Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study\n* Current or recent mood disturbances or Axis I disorders (descriptions will be given)\n* Current misuse of alcohol and\u002For drugs\n* Current smoker\n* Recent (within the last 12 weeks) infection and\u002For use of antibiotic medication\n* Pregnant, seeking to become pregnant or lactating\n* Those using (including within the last 2 weeks) proton-pump inhibitors","25 Years",{"count":426,"type":21},68,[24],"This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.",[430,431,432,433,28],"Stress","Sleep","Cognition","Nutrition",[435,436,437,438],"sleep","gut health","cognition","stress","2026-02-27",{"date":441,"type":33},"2026-03-03",{"date":70,"type":21},{"date":444,"type":21},"2026-12",{"name":446,"class":75},"Northumbria University",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":50,"sex":16,"minAge":454,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":76},"100618581","flourish-exploring-the-early-infant-gut-microbiome-100618581","NCT07333482","Flourish: Exploring the Early Infant Gut Microbiome","Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants","Inclusion Criteria:\n\n* Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.\n* Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent.\n* Infants must have been at least 36 weeks gestation at time of delivery.\n* Infants and their caregivers must reside in the United States with a US mailing address.\n\nExclusion Criteria:\n\n* Infants can not have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.\n* Twin and multiple birth infants are not accepted in this study.\n* Infants cannot have the following existing health conditions:\n* Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS)\n* Immune or auto-immune conditions: Severe Combined Immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes\n* Congenital conditions: cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia)\n* Blood disorders (sickle cell disease, thalassemia, hemophilia)\n* Infant or any immediate family member has previously received results from an at-home microbiome stool test (excluding standard clinical diagnostic testing such as stool culture or pathogen testing)","0 Months","3 Months",{"count":383,"type":21},[24],"The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.\n\nResearchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.\n\nParticipants will:\n\n1. Provide six microbiome stool samples over a 24-month period.\n2. Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.\n3. Receive microbiome reports and guidance according to their assigned study arm.\n4. Complete surveys on infant health history, symptoms, diet, and environmental exposures.\n5. Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.\n\nThis study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.",[460,461,462,28],"Microbiota","Gut Microbiome","Eczema","2026-02-20",{"date":465,"type":33},"2026-02-24",{"date":467,"type":33},"2026-01-31",{"date":72,"type":21},{"name":470,"class":40},"Seeding Inc",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":50,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":478,"targetDuration":455,"studyType":144,"phases":4,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":76},"100624456","an-integrated-multi-omics-study-on-the-molecular-mechanisms-of-ureteral-stricture-100624456","NCT07409870","An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture","US-MOP","Inclusion Criteria (Ureteral Stricture Group):\n\nAge between 18 and 75 years, regardless of gender. Diagnosis of ureteral stricture confirmed by clinical symptoms and imaging (e.g., CT, IVP, or retrograde pyelography) or ureteroscopy.\n\nThe patient is scheduled for or undergoing standard clinical evaluation\u002Ftreatment for ureteral stricture.\n\nWillingness to provide stool, urine, and blood samples. Informed consent signed by the participant or their legal representative.\n\nInclusion Criteria (Healthy Control Group):\n\nAge- and sex-matched volunteers (18-75 years). No history of ureteral stricture, urinary tract obstruction, or significant renal disease.\n\nPhysical examination and laboratory tests (renal function, routine urine analysis) are within normal limits.\n\nExclusion Criteria (Applicable to Both Groups):\n\nUse of antibiotics, probiotics, prebiotics, or antifungal medications within the 4 weeks prior to sample collection.\n\nHistory of chronic gastrointestinal diseases (e.g., Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), or chronic diarrhea).\n\nKnown malignant tumors of the urinary tract or other systemic malignancies. History of major abdominal or urinary tract surgery within the last 3 months (excluding the current planned procedure for patients).\n\nPresence of severe systemic diseases, including uncontrolled diabetes, severe hepatic dysfunction, or end-stage heart failure.\n\nPregnancy or breastfeeding. Any other condition that, in the opinion of the investigator, may interfere with the microbiome or metabolomic analysis.",{"count":479,"type":21},120,"The goal of this observational study is to investigate the systemic pathogenesis and identify potential diagnostic biomarkers in patients with ureteral stricture and healthy volunteers. The main questions it aims to answer are:\n\nWhat are the systemic differences in the gut microbiome, urine microbiome, and metabolomic profiles (fecal, urinary, and serum) between patients with ureteral stricture and healthy controls? What are the correlations between these microbial\u002Fmetabolic alterations and clinical phenotypes, such as stricture severity, inflammatory levels, and renal function? Researchers will compare the biological panoramic profiles of patients with ureteral stricture to those of healthy controls to see if specific \"microbiome-metabolite-disease\" regulatory networks drive the development of the condition.\n\nParticipants will:\n\nProvide stool samples for gut microbiome (16S\u002FMetagenomics) and metabolomic analysis.\n\nProvide urine samples for urine microbiome and metabolomic analysis. Provide blood (serum) samples for systemic metabolomic profiling. Undergo clinical assessments, including medical history collection, imaging (e.g., CT\u002FIVP), and laboratory tests (e.g., renal function, inflammatory markers) to evaluate disease severity.",[482,483,28,484],"Ureteral Stricture","Ureteral Obstruction","Metabolomics","2026-02-07",{"date":487,"type":33},"2026-02-13",{"date":210,"type":21},{"date":490,"type":21},"2026-07-31",{"name":492,"class":75},"First Affiliated Hospital of Chongqing Medical University",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":16,"minAge":109,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":502,"conditions":503,"keywords":509,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":320},"100562665","the-role-of-brain-bone-marrow-gut-interaction-following-major-trauma-100562665","NCT06606119","The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma","Severe Trauma Cohort\n\nInclusion Criteria:\n\n1. All adults (age ≥18).\n2. Blunt trauma with an injury severity score \\> 15 and a long bone or pelvic fracture requiring open reduction internal fixation or intramedullary fixation\n3. Blunt trauma patients with shock, defined by either a systolic BP (SBP) \\\u003C90 mm Hg or base deficit (BD) ≥5 meq or lactate ≥ 2 mmol\u002FL or active red blood cell or whole blood transfusion within 6h or arrival\n\nExclusion Criteria:\n\n1. Patients not expected to survive greater than 48 hours\n2. Prisoners\n3. Pregnancy\n4. Previous bone marrow transplantation\n5. Patients receiving chronic corticosteroids or immunosuppression therapies\n6. Patients with End Stage Renal Disease\n7. Patients with any pre-existing hematological disease\n8. Surgery for repair of injury is greater than seven days after admission to the hospital for trauma\n9. Burn injury greater than 20% TBSA\n\nElective Hip Cohort\n\nInclusion Criteria\n\n1. All adults (age ≥55).\n2. Patient undergoing elective hip repair for non-infectious reasons.\n3. Ability to obtain Informed Consent prior to operation.\n\nExclusion Criteria\n\n1. Patients not expected to survive greater than 48 hours\n2. Prisoners\n3. Pregnancy\n4. Previous bone marrow transplantation\n5. Patients receiving chronic corticosteroids or immunosuppression therapies\n6. Patients with End Stage Renal Disease\n7. Patients with any pre-existing hematological disease","100 Years",{"count":501,"type":21},275,"Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery. This project will define the interactions between the stress, chronic inflammation, bone marrow dysfunction, and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma.",[504,505,506,28,507,508],"Trauma Injury","Trauma","Critical Illness","Chronic Anemia","Acute Blood Loss Anemia",[510,511,512,461,513,514],"Hematopoietic Stem Progenitor Cells","Bone Marrow Failure","Anemia","Inflammation","Dysregulated Stress Response","2026-02-04",{"date":517,"type":33},"2026-02-06",{"date":519,"type":33},"2025-01-24",{"date":521,"type":21},"2028-10-01",{"name":523,"class":75},"University of Florida",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":76},"100612170","the-role-of-microbiota-in-pancreatic-cancer-and-precursor-lesions-100612170","NCT07250100","The Role of Microbiota in Pancreatic Cancer and Precursor Lesions","MICROPAC","Inclusion Criteria:\n\n* Patients with a suspected lesion (solid\u002Fcystic) in the pancreas undergoing diagnostic or therapeutic endoscopic procedure\n* Age of 18 years or above\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy",{"count":532,"type":21},300,"This is a prospective observational study aiming to investigate the microbiome in patients suspected of having pancreatic cancer. The purpose is to enhance diagnostic accuracy by developing screening protocols for high-risk individuals, identifying specific microbial biomarkers, and improving prognostic criteria to optimize treatment response.\n\nParticipants will be asked to complete a questionnaire, provide oral and fecal swabs, and-if clinically indicated-1-2 pancreatic biopsies will be collected.",[535,28],"Pancreatic Cancer","2025-11-18",{"date":538,"type":33},"2025-11-26",{"date":540,"type":33},"2025-11-01",{"date":542,"type":21},"2037-12",{"name":544,"class":75},"Herlev Hospital",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":200,"minAge":109,"maxAge":83,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":560,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":76},"100478064","early-phase-1-modification-of-the-early-life-respiratory-microbiome-through-vaginal-seeding-100478064","NCT05505110","MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing","MOTHER SEED","Inclusion Criteria:\n\nFor the mother:\n\n* Female 18-40 years of age who is in good general health, is fully able to provide consent to participate in the study, anticipates being available for the duration of the study, and is willing to comply with all study procedures\n* Singleton pregnancy\n* Completed ≧3 prenatal care visits at Vanderbilt University Medical Center (any facility)\n* Having rectovaginal swabs collected at ≧36 weeks of gestation to screen for Group B Streptococcus (GBS) as part of prenatal screening tests\n* Having a scheduled (planned or non-emergency) C-section at Vanderbilt University Medical Center (main campus only)\n* No intent to relocate outside the middle Tennessee region within 12 months of recruitment\n\nFor the child:\n\n* Estimated gestational age ≧37 weeks\n* Birth weight ≧2,500 grams\n\nExclusion Criteria:\n\nFor the mother:\n\n* Past medical history of any of the following:\n\n  * Previous child with GBS infection or prior positive GBS testing\n  * Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection\n  * Genital herpes simplex virus (HSV) infection, genital herpetic lesions, or prior positive genital HSV testing\n  * Genital human papilloma virus (HPV) infection, genital HPV lesions, or prior positive genital HPV testing\n  * Diabetes type I or type II\n* Laboratory evidence during the current pregnancy of any of the following:\n\n  * GBS bacteriuria in urine samples collected at any time (performed as standard of care)\n  * GBS colonization in rectovaginal swabs collected at ≧36 weeks of gestation (performed as standard of care)\n  * Chlamydia, trichomoniasis, or gonorrhea in urine samples collected at ≧36 weeks of gestation (performed as part of the screening procedures for this study)\n  * Hepatitis B, hepatitis C, HIV, or syphilis in blood samples collected at ≧36 weeks of gestation (performed as part of the screening procedures for this study)\n* Uncontrolled gestational diabetes\n* Any serious obstetric disease (e.g., preeclampsia with severe features, placental abruption or severe bleeding, or thromboembolic disease) as deemed by the PI or co-investigators\n* Prior abnormal Pap smear\n* C-section scheduled for a genitourinary infection that would have interfered with vaginal delivery (e.g., genital herpetic lesions)\n* Lack of available prenatal screening tests\n* Use of systemic (i.e., oral, intramuscular, or intravenous) antibiotics in the 4 weeks prior to delivery (except for those being administered as part of the C-section)\n* Use of systemic (i.e., oral, intramuscular, or intravenous) immunosuppressive, biologic, or chemotherapeutic agents in the 3 months prior to delivery (except for systemic immunosuppressive agents not being used for their immunosuppressive effects \\[e.g., prenatal intramuscular beclomethasone for fetal lung maturation\\])\n* Fever (≧100.4°F \\[38°C\\]) in the 72 hours prior to delivery\n* Symptoms (e.g., dysuria, pruritus, or discharge) suggestive of a genitourinary infection (e.g., bacterial vaginosis, vaginal yeast infection, chorioamnionitis, or urinary tract infection) on the day of delivery\n* Symptoms (e.g., pain, tenderness, tingling, burning, itching, or swollen lymph nodes) suggestive of genital HSV infection on the day of delivery\n* Other symptoms (e.g., new-onset rhinorrhea, sore throat, cough, body aches, chills, nausea, vomiting, or diarrhea) suggestive of an acute infectious disease on the day of delivery\n* Physical exam findings (e.g., fever \\[≧100.4°F (38°C)\\] or vesicles, warts, or ulcers in the genital, perineal, or anal region) suggestive of a genitourinary infection on the day of delivery (performed as part of the screening procedures for this study if not performed as standard of care)\n* Maternal vaginal pH\\>4.5 on the day of delivery (performed as part of the screening procedures for this study)\n* Need for a switch from a scheduled C-section to an emergency C-section\n* Prelabor prolonged rupture of membranes (i.e., ≧18 hours prior to delivery)\n* Pregnancy as the result of an assisted reproductive technology or surrogacy\n* Participation in another clinical trial that involves an intervention that could impact the quality or interpretation of the study data as deemed by the PI or co-investigators\n* Other past or current medical problems that could compromise the safety of participants, interfere with their ability to comply with study requirements, or impact the quality or interpretation of the study data as deemed by the PI or co-investigators\n\nFor the child:\n\n* Need for neonatal measures outside routine clinical care (i.e., drying, tactile stimulation, bulb syringe or catheter suction of nose and mouth, or temperature maintenance) in the delivery room\n* Transfer to the neonatal intensive care unit immediately after delivery\n* Thick particulate meconium noted during delivery\n* Physical exam findings (e.g., tachypnea, nasal flaring, retractions, cyanosis, or grunting) suggestive of neonatal acute respiratory distress immediately after delivery (performed as part of the screening procedures for this study)\n* Prenatal diagnosis of a serious genetic, respiratory, cardiovascular, or neurological disease\n* Prenatal diagnosis of intrauterine growth restriction\n* Prenatal diagnosis of a major congenital anomaly (e.g., cleft lip or palate, cystic hygroma, or giant omphalocele)\n* Participation in another clinical trial that involves an intervention that could impact the quality or interpretation of the study data as deemed by the PI or co-investigators\n* Other past or current medical problems that could compromise the safety of participants, interfere with their ability to comply with study requirements, or impact the quality or interpretation of the study data as deemed by the PI or co-investigators",{"count":553,"type":21},20,[88],"This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of children born by cesarean section (C-section) is feasible and that the intervention is safe.",[557,558,559,28],"C-section","Vaginal Seeding","Respiratory",[557,561,559,28],"Vaginal seeding","2025-11-06",{"date":564,"type":33},"2025-11-10",{"date":566,"type":33},"2022-11-09",{"date":568,"type":21},"2028-08-10",{"name":570,"class":75},"Vanderbilt University Medical Center",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":50,"sex":16,"minAge":578,"maxAge":109,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":76},"100504731","phase-1-oral-changes-with-caloric-and-no-caloric-sweeteners-100504731","NCT05852145","Oral Changes With Caloric and no Caloric Sweeteners","Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents","Inclusion Criteria:\n\n* Habitual consumption of soft drinks\n* Decayed, Missing, and Filled Teeth (DMF) index of at least 3 (considering as caries those lesions that are visible without the tooth needing to be dry)\n* Agree to participate in the study and sign informed consent\n* Parents sign informed consent\n* Any nutritional condition\n\nExclusion Criteria:\n\n* Orthodontic treatment\n* Topical application of fluoride during the last 3 months\n* Having a motor disability that interfered with tooth brushing\n* Xerostomia\n* Antibiotic therapy during the study period\n* Periodontal infections","12 Years",{"count":580,"type":21},52,[582,228],"PHASE1","The objective of this clinical trial is to compare the effect that the intake of beverages without sweeteners, added with non-caloric sweeteners (stevioside) and caloric sweeteners (sucrose) on oral pH and dental biofilm microbiome in Mexican adolescents.\n\nParticipants will drink on different occasions a beverage without sweetener, a beverage added with stevioside or a beverage added with sucrose. The researchers will compare the changes that each one causes in salivary pH, dental biofilm pH, dental biofilm bacterial proliferation and dental biofilm microbiome.",[585,28,586],"pH","Dental Plaque",[588,589,585,590,591,592],"artificial sweetener","stevioside","caries","sucrose","dental biofilm","2025-10-07",{"date":595,"type":33},"2025-10-09",{"date":597,"type":33},"2025-08-01",{"date":599,"type":21},"2026-04",{"name":601,"class":75},"Hospital Infantil de Mexico Federico Gomez",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":16,"minAge":328,"maxAge":110,"enrollmentInfo":610,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":612,"conditions":613,"keywords":617,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":76},"100609011","dynamics-of-dysbiosis-in-the-skin-and-gut-microbiome-of-burn-patients-100609011","NCT07209007","Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients","An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients","BURN-MICRO","Inclusion Criteria\n\n* Adults aged 19 to 65 years\n* Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment\n* Ability to understand study objectives and provide written informed consent\n\nExclusion Criteria\n\n* Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection\n* Pregnancy or breastfeeding\n* Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome\n* Active infections at the sampling site\n* Any medical condition judged by the investigator to make participation inappropriate",{"count":611,"type":21},600,"This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood.\n\nIn this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only.\n\nMicrobial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured.\n\nThe findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.",[614,615,28,616],"Burn Injuries","Skin Disease","Microbiome Dysbiosis",[618,619,461,118,620],"Burn Injury","Skin Microbiome","16S rRNA Sequencing","2025-09-29",{"date":623,"type":33},"2025-10-06",{"date":625,"type":33},"2025-09-15",{"date":627,"type":21},"2030-12-31",{"name":629,"class":75},"Cho Yoon soo",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":50,"sex":327,"minAge":109,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":639,"conditions":640,"keywords":645,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":76},"100575884","sti-prophylaxis-and-emergence-of-antimicrobial-resistance-100575884","NCT06778083","STI Prophylaxis and Emergence of Antimicrobial Resistance","SPEAR","Inclusion Criteria:\n\n* Aged ≥ 18 years.\n* Identifies as a man (cis or trans).\n* Has sex with men.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Use of an antibiotic other than doxycycline in the 3 months prior to enrolment\n* Currently being treated for an STI with doxycycline\n* Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.",{"count":638,"type":21},108,"The goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (STI prophylaxis, doxycycline post-exposure prophylaxis, or 'doxyPEP'). The study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (MSM) who use STI prophylaxis.\n\nThe study will recruit 108 MSM who are using and not using STI prophylaxis. Participants will visit the clinic every 6 months. At each visit, they will provide a throat swab and stool sample, and complete a questionnaire. DNA of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.",[641,642,643,28,644],"Sexually Transmitted Infection (STI) Prevention","Antibiotic Prophylaxis","Antibiotic Resistance, Bacterial","Doxycycline",[646,647,644,648,279,649,28,650],"DoxyPEP","STI Prophylaxis","STI Prevention","Antibiotic Resistance","Men-who-have-sex-with-men","2025-03-26",{"date":653,"type":33},"2025-03-27",{"date":655,"type":33},"2025-02-10",{"date":657,"type":21},"2027-04-30",{"name":659,"class":75},"University College, London",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":16,"minAge":109,"maxAge":224,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":681,"locationsCount":76},"100436990","phase-1-microbial-restoration-in-inflammatory-bowel-diseases-100436990","NCT04970446","Microbial Restoration in Inflammatory Bowel Diseases","The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases","MIRO II","Inclusion Criteria:\n\nActive Crohn's disease\n\n* Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND\n* CDAI score of 220-450 AND\n* One of the following:\n\n  * CRP ≥5mg\u002FL\n  * faecal calprotectin ≥100μg\u002Fg\n  * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)\n* Willing and able to attend the study sites for regular endoscopic procedures.\n\nExclusion Criteria:\n\nActive perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109\u002FL; Albumin less than 20g\u002FL; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis\u002Fsevere allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \\>20mg or budesonide dose \\>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.",{"count":479,"type":21},[582,228],"This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.",[672,673,674,28],"Fecal Microbiota Transplantation","Crohn Disease","Inflammatory Bowel Diseases","2025-02-23",{"date":677,"type":33},"2025-02-26",{"date":679,"type":33},"2022-05-01",{"date":367,"type":21},{"name":682,"class":75},"St Vincent's Hospital Melbourne"]